LivingGLP1
Study S001353

Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT03989232
Acronym
SUSTAIN FORTE
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
961
Start
2019-06-19
Primary completion
2020-09-18
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1224-5162; REGISTRY:2018-004529-96; NIH:2018

Registered primary outcomes

  • Change in HbA1c [Week 0, week 40]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0050541Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial
Slobodan I Macura, Carolina Digital Repository (University of North Carolina at Chapel Hill)
2024Randomized trialDOIcites ClinicalTrials.gov:NCT03989232; cites EudraCT:2018-004529-96
R0022738Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial.
Frías JP, The lancet. Diabetes & endocrinology
2021Randomized trialPMID 34293304DOIcites ClinicalTrials.gov:NCT03989232; cites EudraCT:2018-004529-96; registry reference RESULT:34293304
R0050403101-OR: Efficacy and Safety of Once-Weekly Semaglutide 2.0 vs. 1.0 mg for Type 2 Diabetes: SUSTAIN FORTE Randomized Trial
Juan P. Frías, Diabetes
2021Randomized trialDOIcites ClinicalTrials.gov:NCT03989232